AuroMedics Pharma LLC recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed
AuroMedics recalls 0.5% Moxifloxacin eye drops due to discoloration complaints. Affected lots from India with specific expiration dates. Stop using if discoloration occurs.
Lower-risk recall
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Contact the company & request your remedy
What happened, in plain English
AuroMedics is recalling certain moxifloxacin eye drops because customers reported discoloration. This could affect eye health if the solution is used improperly. Read more at govinfonow.com/recall/37666-auromedics-moxifloxacin-eye-drops-recall-discoloration-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37666-auromedics-moxifloxacin-eye-drops-recall-discoloration-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0789-2020
Cite this page
“AuroMedics Moxifloxacin Eye Drops Recall: Discoloration Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37666-auromedics-moxifloxacin-eye-drops-recall-discoloration-risk. Based on FDA recall #D-0789-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0789-2020%22&limit=1).
Why it’s dangerous
Discoloration in the eye drop solution may indicate contamination or degradation. Using discolorated drops could potentially cause eye irritation or infection.
Who’s affected
Patients prescribed this medication by a doctor are affected. Those using the product without a prescription or for non-ophthalmic purposes are not covered.
How to tell if you have this one
Check for discoloration in the 3mL bottle labeled Moxifloxacin Ophthalmic Solution 0.5%. The product was distributed with specific lot numbers and expiration dates.
- Brand
AuroMedics- Category
Drug
What to do — step by step
Check for Discoloration
Inspect the eye drop solution for any discoloration before use.
Questions people ask
Is this product safe to use?
The recall is due to discoloration complaints, not safety issues. If the solution appears normal, it may be safe to use as directed.
What should I do if I have discoloration?
Stop using the product immediately and contact your doctor for advice.
How can I tell if I have the recalled product?
Look for the 3mL bottle with lot numbers CMF190008, CMF190009, CMF190025, or CMF190026, and expiration dates of 04/2021 or 06/2021.
Contact AuroMedics
We’ve drafted a message you can send AuroMedics to request your refund or repair — edit it as you like.
Subject: Recall D-0789-2020 — AuroMedics AuroMedics Hello, I own a AuroMedics that is covered by recall D-0789-2020 from AuroMedics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0789-2020 (December 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0789-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.